Status:
ACTIVE_NOT_RECRUITING
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Lead Sponsor:
Astria Therapeutics, Inc.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive ...
Eligibility Criteria
Inclusion
- Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
- Completed STAR-0215-201 (follow up through 6 months after their last dose);
- Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
- Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
- Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
- Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).
Exclusion
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
- Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
- Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
- Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
- lanadelumab within 90 days
- berotralstat within 21 days
- all other prophylactic therapies, discuss with the Medical Monitor
- Note: Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06007677
Start Date
September 26 2023
End Date
March 1 2031
Last Update
July 23 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Allervie Clinical Research
Birmingham, Alabama, United States, 35209
2
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, United States, 85251
3
Acuro Research
Little Rock, Arkansas, United States, 72205
4
UC San Diego US HAEA Angioedema Center
San Diego, California, United States, 92122